The invention relates to medicine, to appliances and methods of carrying out surgical operations and manipulations. In particular, the invention relates to medicinal materials used in surgery in plastic cosmetic operations.
Surgical suture material, that is, needles with threads for sewing up the edges of wounds in surgical operations, threads for cosmetically tightening soft tissues with needles of different forms or without them, but with special devices for introducing the needles into the tissues, are known:                Application PCT/RU2004/000252 of Jun. 30, 2004.        EP 0205811 A1 of Dec. 30, 1986.        RU 2186536 C2        U.S. Pat. No. 5,342,376 of Aug. 30, 1994.        
The needles are manufactured from metal, most frequently steel, they can be straight or bent around their circumference, or have another shape. At one end there is a point, while at the other end there is an eye for inserting a surgical suture thread. For sewing up the edges of wounds, atraumatic needles have been used during the past decades, which lack the eye, while the suture thread is fastened to the needle by an industrial method, which allows the surgeon to use disposable sterile suture material, and most importantly a needle which does not comprise a bulky eye and a double thread. Such a needle marginally traumatizes the soft tissues when the needle with the thread is passed therethrough.
The needle can be double-pointed, and the thread can be connected to it in the centre or at the extension. The shape of the needle is determined by the method of its application in the surgical operation.
The threads, which are atraumatically connected with the needles, can be manufactured from different non-absorbing or absorbing materials, with different thickness and strength, integrally (in one filament), woven, spun, or coated with a different material.
The general characteristics of surgical needles are: strength, a smooth surface, biological inertness. They must penetrate the skin easily and pass freely through the subcutaneous tissues. For sewing up open wounds in a continuous suture process, suture materials with bent needles are used, straight needles are not useful in this case.
Surgical needles can be smooth, coarse, and can also have protrusions arranged at an angle on their surface.
Methods for arranging surgical sutures for sewing up wounds or sewing subcutaneous tissues are known: interrupted sutures, mattress sutures, continuous sutures, etc. The sewing of subcutaneous tissues is carried out in the open wound for sewing its edges up, without incisions of the skin through punctures for tightening the soft tissues, and through short incisions of the skin when an endoscopic operation is carried out. The latter two approaches are usually employed in aesthetic surgery for sewing and tightening of ptotic subcutaneous tissues and fastening them in a new and higher position, which renders a better aesthetic result. These operations and manipulations are easily and well carried out only with suture threads with double-pointed needles.
The known suture material with protrusions for sewing up the edges of wounds with perpendicular single stitches (U.S. Pat. No. 5,053,047 of Oct. 1, 1991), and also for a continuous subcutaneous and intracutaneous sewing up of wound edges, has some negative properties, which prevent the implementation of quality surgery.
In sewing up open wounds with the method claimed in US WO-A-98/52473 of May 21, 1997, the skin edges of the wound are positioned badly with respect to each other if only subcutaneous sutures are applied. If, however, such sutures are applied intracutaneous, they become visible, and, since the claimed method for sewing wounds does not provide for a removal of the sutures after the wound is healed, this factor does not allow to obtain an aesthetically acceptable post-operational scar. A further downside of said method are the high costs of the operation, since for the same length of the wound, several times the amount of suture material is needed compared to the continuous sewing method.
The sewing devices claimed in the US patents are so bulky that it is impossible to apply continuous sutures and to obtain unobtrusive scars with them.
The suture material according to EP 1075843 is also fairly expensive—with a unit of such suture thread a wound of only 10 cm in length can be sewn up (else the removal of the thread after the healing of the wound becomes difficult), while sewing up wounds with conventional atraumatic smooth threads is possible for single cuts of 7-10 cm with the entire length of suture thread (approximately 45 cm).
According to EP 1 075 843, the amount, strength, and also the durability of the engagement of the seams of the second set with the tissues is insufficient for keeping the free end of the thread from slipping into the depth of the wound. At the same time, the strength and durability of the engagement of the seams of the first set with the tissues is abundant. The fact is that according to the invention each seam on the right and on the left has the same strength, and also the distance between them is equal. With each applied stitch, when the thread is tightened and the edges of the wound are crimped to some extent, the tension on the very first seam of the second set is gradually increased. At some point it will fail to stand this, will bend or tear, and the thread will slip into the depth of the wound in one turn. If the tension continues to increase, the same will happen to the second seam and so on, hence the end of the thread can slip under the skin. Even if that does not happen, the entire construction can still slacken at the instant when the operation is finished, and there is a risk that the suture turns out to be unstable.
According to EP 1 075 843 the conically shaped protrusions claimed in the invention do not reliably keep the tissues in a tightened state. The fact is that when the thread is tightened to the opposite side and the pressure on the protrusions is gradually increased, they will spread out, become arranged perpendicularly with respect to the thread and then bend, and the thread will slip into the tissue in one or several turns. That is, the protrusions on the threads, when a tightening is carried out, will not turn into hooks engaging the tissues, but will simply bend away, as is confirmed in the specification, and this is insufficient for a reliable fixation of the thread with the protrusions in the tissues. This is particularly important for the second group of seams.
In surgical practice there are cases when during the sewing up of a wound a considerable force is necessary for contracting the edges. Here, the surgeons have to carry out a wide mobilization of skin-fat patches from both sides of the wound, which is not always technically possible, and also apply a large number of multi-layer and frequent single sutures in the subcutaneous layers as well as on the skin. For wounds spreading over a large area, single sutures applied on the edges of the wound (especially on subcutaneous fat cell tissues) often get perforated, since with conventional suture needles it is impossible to keep a sufficient volume of tissue in the loop.
The wide mobilization of tissues, the application of a large number of sutures on the edge of the wound and the considerable tension of the skin around the edges of the wound results in additional traumatisation of the edges of the wound as well as of the adjacent portions, prolongs the process of healing of the wound, increases the risk that its edges spread out, and finally renders a rough broad scar.
The usage of double-pointed surgical needles (PCT/RU2004/000252 of Jun. 30, 2004) for tightening soft tissues showed that this suture material has some negative properties.
Although a sewn and tightened portion of flabby soft tissues without apparent cuts, without rough retractions of the skin, with an even, smooth contour is obtained, a relapse of deformations occurs fairly soon (after 4-10 months), and the patients are not satisfied with such short-lived results. The cause for this failure is that the threads used for sewing are smooth and the tissues tightened by them swiftly and easily slip away downwards.
The “APTOS” threads according to RU 2268752 (PCT/RU 02/00285) also have negative properties.
When they are used for tightening soft flabby tissues by the means claimed in the patent, the results of the operations are also short-lived. The fact is that the protrusions on the “APTOS” threads according to said patent are arranged so that in the tissues one half of them works against the other half. Irrespective of whether these protrusions are arranged opposite each other on the different halves of the thread (left or right of the centre of the length of the thread) or whether they alternate, their quantity and also the strength of each are occasionally insufficient for supporting the entire conglomerate of soft tissues.
Moreover, when the thread is not guided into the opening of the needle carefully, the protrusions (especially those which point to the side of the movement of the thread) can bend and not spread out in the tissues, which causes a one-sided weakening of the thread engagement.
The weakness of the protrusion is explained by the shortcoming of its design, and the insufficient quantity is explained by the fact that the protrusions tighten the ptotic tissues only on one half of the length of the thread, while the protrusions of the other half fixate and support the protrusions of the first half.
Considering these shortcomings of employed suture materials and methods of their use, it is expedient to employ a new, more effective surgical material with protrusions on the threads, with the help of which a more reliable sewing of operation wounds with a continuous cosmetic suture is possible, to apply a new, more effective method of contracting the edges of such operation wounds, which require a considerable force for doing so, and to employ a new surgical suture material, which allows a combination of the possibilities of the method of internally sewing soft tissues with the aid of double-pointed needles and the methods of tightening with “APTOS” threads and protrusions, to suggest new and effective operations for tightening ptotic tissues of the face, the body and the extremities.